Volz H P, Heimann H, Bellaire J, Laux G, Möller H J
Department of Psychiatry, University of Bonn, Germany.
Pharmacopsychiatry. 1994 Jul;27(4):152-8. doi: 10.1055/s-2007-1014296.
In a controlled, double-blind, comparative four-week trial on reactive or neurotic major depressed inpatients, the efficacy and safety of the new selective and reversible inhibitor of monoamine oxidase type A, brofaromine, was evaluated in three dose steps (50 mg/day [N = 13], 100 mg/day [N = 12], and 150 mg/day [N = 11]) versus 20 mg tranylcypromine/day (N = 11). In the four groups a pronounced reduction of the depressive symptomatology (measured by the Hamilton Depression Scale, the Zung Self-Rating Scale of Depression, and by a global evaluation of efficacy) was found, but it was not possible to show any differential effect. The safety parameters in all groups were comparable. The results of the trial are compared with other trials of monoamine oxidase inhibitors in this patient group and the possible reasons for the lack of a clear dose-response relationship are discussed.
在一项针对反应性或神经性重度抑郁住院患者的为期四周的对照、双盲、比较性试验中,对新型选择性可逆A型单胺氧化酶抑制剂溴法罗明进行了三个剂量水平(50毫克/天 [N = 13]、100毫克/天 [N = 12] 和150毫克/天 [N = 11])的疗效和安全性评估,并与每天20毫克反苯环丙胺(N = 11)进行比较。在这四组中,均发现抑郁症状(通过汉密尔顿抑郁量表、zung抑郁自评量表以及疗效整体评估来衡量)有显著减轻,但未能显示出任何差异效应。所有组的安全参数具有可比性。将该试验结果与该患者群体中其他单胺氧化酶抑制剂试验进行了比较,并讨论了缺乏明确剂量反应关系的可能原因。